Intubation devices, such as oral-endotracheal tubes, are utilized in a wide variety of medical situations to provide an unobstructed conduit to a patient's trachea in which oxygen, medications and therapies can be passed. In most situations in which medical attention is needed, medical personnel will first determine the ability of the patient to maintain their airway. Often these emergent evaluations are performed by individuals having inadequate training and knowledge in airway management. The inability to secure an airway and provide a route of ventilation in someone whose airway is threatened, compromised, or obstructed can quickly result in irreversible brain damage and death.
Placement of an intubation device, such as an endotracheal tube, into the tracheobronchial tree of a patient is accessed via the nasal or oral opening. In a few select situations nasal intubation is indicated, however, the vast majority of airways are secured via the oraltracheal route. Placement of an endotracheal tube, however, is often found to be a difficult procedure, even by well-trained, experienced personnel. This difficulty can be attributed to the anatomical variations or the encountered situation in which the airway needs to be secured. Further, during the process of placing an endotracheal tube into the trachea of a patient, it is not uncommon that only minimal visualization of the laryngeal anatomy can be obtained thereby increasing the chances that esophageal intubation can occur. Thus, the ability to “blindly” place an endotracheal tube properly into the trachea of a patient is directly proportional to the medical personnel's experience and the availability of additional intubation devices available.
Endotracheal tubes are generally formed of soft, pliable plastic materials, that increase in plasticity in the warm humidified air encountered when passing through the hypopharynx, thereby increasing the difficulty of placing an endotracheal tube through the glottic opening even under the most optimal visualization. Making the endotracheal tube out of a stiffer material, however, is not an acceptable alternative because it would cause excessive trauma to the nasal or throat tissue as the laryngeal and surrounding mucosa is extremely sensitive to manipulation. This can result in significant swelling and decreased visualization, which prevents or hinders oral tracheal intubation thereby placing the patient's life in great jeopardy. To overcome this problem, intubation devices often have a removable stylet made out of a somewhat malleable material that is telescopically placed within the endotracheal tube and has a sufficient amount of stiffness in order to maintain the tubes desired contour and to aid in tracheal intubation.
The stylet, which has gained the most acceptances for oral intubation, is a “pre-bend” stylet made of a rigid, malleable material such as rubber or plastic coated metal. Typically, during the intubation process, the medical personnel performing the process inserts the stylet into the endotracheal tube and folds one end of the stylet around the outboard end of the tube. The tube and the stylet are then molded to approximately conform to what is believed to be the route of passage to the laryngeal inlet. With the help of a laryngoscope, the medical personnel inserts the stylet and the endotracheal tube into the patient's mouth and hypopharynx until it reaches the patient's trachea. If needed, after visualizing the hypopharynx, the tube and stylet can be removed and the contour adjusted if necessary. Unfortunately, it is difficult for medical personnel, even after extensive training, to predetermine the proper contour that the endotracheal tube should be molded to for placement into the patient's trachea. Accordingly, it is not uncommon to fail in the first attempt to intubate the patient. In such an event, medical personnel must then remove the tube and the stylet from the patient, adjust their contour, re-ventilate the patient, and reinsert the now adjusted tube and stylet into the patient. Such removal and reinsertion of the endotracheal tube and stylet results in valuable time lost and may also result in damage to the patient's soft airway tissue thereby significantly increasing the likelihood of loss of visualization of the laryngeal anatomy and the time for oxygen delivery. Further, sterility of the endotracheal tube may be sacrificed when the user grasps the stylet to rebend the stylet into the proper contour.
In order to overcome some of the problems encountered with such intubation devices, mechanical guides have been developed to assist intubation of endotracheal tubes. It has been found that such mechanical guides are typically difficult to manipulate with one hand and do not allow for delicate control or provide the proper sensitivity necessary to intubate a patient quickly with a minimum amount of trauma to sensitive tissue. Accordingly, such mechanical guides have not met with widespread commercial success or recognition in the medical field and the malleable or “prebend” stylet is still the predominate oral intubation aid used. Further, such guides are also typically formed from materials that are sufficiently rigid to maintain a desired contour. Accordingly, such guides have been found to cause trauma to sensitive tissue.
It is therefore desirable to have an intubation device that can be quickly and easily inserted to form an unobstructed conduit to a patient's trachea in which oxygen, medications and therapies can be passed, that reduces the likelihood of trauma to the sensitive nasal or throat tissue of the laryngeal and surrounding mucosa, that reduces the chances of compromising the sterility of the device, and which can be relatively inexpensive to manufacture.